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Completed

NCT Number: NCT05396963

Egg White Supplementation in High-Intensity Functional Training

High-intensity functional training (HIFT), a new version of high-intensity interval training, has gained interest in recent years. HIFT is based on the CrossFit training template and includes multijoint movement patterns via both endurance and strengthening exercises. Research has shown positive effects of HIFT on body composition, cardiorespiratory fitness, and muscle performance of young individuals. The effectiveness of HIFT in higher ages and its protein requirements are less well documented. Protein requirements have been widely investigated in resistance training, where it has been found that protein supplementation may have additive beneficial effects on muscle strength and lean body mass. However, there is a research gap regarding the adaptations to HIFT when combined with protein supplementation.

Thus, the aim of this research is to compare the effects of egg white supplementation, whey protein supplementation (as a positive comparator), and maltodextrin (a carbohydrate as placebo) on body composition, physical performance, and plasma amino acid profile in young and middle-aged trained individuals of both sexes who perform HIFT. Participants will take all three supplements for 6 weeks each, with 2 weeks of washout (no supplementation) in between, in random and counterbalanced order. Researchers will not know the supplementation status of the participants. Participants will receive 0.6 g of protein or placebo per kg body weight daily on top of isoenergetic dietary plans to avoid differences in energy intake that might compromise the validity of the study. The dietary plans will be individualized and will provided 1.0 g protein/kg body weight/day. The HIFT protocol will include multimodal patterns of movement, combining endurance and strengthening exercises with the use of equipment such as Total Resistance eXercise (TRX), Bosu, kettlebells, and barbells.

Participants will undergo measurements of muscle strength, muscle endurance, aerobic capacity, and body composition at the beginning and end of the study, as well as during the two washout periods. Also, plasma amino acids, hematology, biochemistry, and hormones will be measured. Comparison of all these outcome measures between supplements will reveal whether protein supplementation is useful in HIFT.

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Key information

Conditions

Exercise Training Dietary Supplements

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Evaluation of Human Biological Performance

Thessaloniki, 57001, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Regular training (mixed endurance and resistance training 3 to 6 times a week, 50 min each session, for the past 4 months), as assessed by gym records or questionnaires
  • Clearance from a pathologist or cardiologist to perform maximal exercise
  • Mixed isoenergetic diet for the past 4 months

Exclusion criteria

  • Smoking (even one cigarette or nicotine-containing device over the past 6 months)
  • Any injuries to the musculoskeletal system that could interfere with the execution of training
  • Chronic disease
  • Egg allergy
  • Milk allergy
  • Pregnancy, lactation, or planning a pregnancy within the duration of the study
  • Regular use of prescription medicine or supplements that might affect muscle function or recovery over the past month
  • Intermittent or religious fasting
  • Any vegetarian, ketogenic or protein diet

Treatment and study plan

Egg white

Dietary Supplement

Intake of egg white

Whey Protein

Dietary Supplement

Intake of whey protein

Maltodextrin

Dietary Supplement

Intake of maltodextrin

Primary outcomes

  1. Lean and fat mass pre-supplementation

    Time frame: Within 2 weeks before the beginning of supplementation.

    Lean and fat mass of the whole body and its parts (trunk, legs and arms) will be assessed by dual X-ray absorptiometry.

  2. Lean and fat mass post-supplementation

    Time frame: Within 2 weeks after the end of supplementation.

    Lean and fat mass of the whole body and its parts (trunk, legs and arms) will be assessed by dual X-ray absorptiometry.

  3. Maximal dynamic strength of shoulder muscles pre-supplementation

    Time frame: Within 2 weeks before the beginning of supplementation.

    Maximal dynamic strength of shoulder muscles will be assessed by measurement of one-repetition maximum.

  4. Maximal dynamic strength of shoulder muscles post-supplementation

    Time frame: Within 2 weeks after the end of supplementation.

    Maximal dynamic strength of shoulder muscles will be assessed by measurement of one-repetition maximum.

  5. Force-velocity relationship of knee flexors and extensors pre-supplementation

    Time frame: Within 2 weeks before the beginning of supplementation.

    Force-velocity relationship of knee flexors and extensors will be assessed in isokinetic dynamometer.

  6. Force-velocity relationship of knee flexors and extensors post-supplementation

    Time frame: Within 2 weeks after the end of supplementation.

    Force-velocity relationship of knee flexors and extensors will be assessed in isokinetic dynamometer.

  7. Plasma amino acid profile pre-supplementation

    Time frame: Within 4 days before the beginning of supplementation.

    Plasma amino acid profile (that is, the concentration of each individual amino acid) will be determined by liquid chromatography - mass spectrometry.

  8. Plasma amino acid profile post-supplementation

    Time frame: Within 4 days after the end of supplementation.

    Plasma amino acid profile (that is, the concentration of each individual amino acid) will be determined by liquid chromatography - mass spectrometry.

  9. Aerobic fitness pre-supplementation

    Time frame: Within 2 weeks before the beginning of supplementation.

    Aerobic fitness will be assessed by measurement of maximal oxygen uptake through a maximal graded exercise test on treadmill.

  10. Aerobic fitness post-supplementation

    Time frame: Within 2 weeks after the end of supplementation.

    Aerobic fitness will be assessed by measurement of maximal oxygen uptake through a maximal graded exercise test on treadmill.

  11. Muscle endurance pre-supplementation

    Time frame: Within 2 weeks before the beginning of supplementation.

    Muscle endurance will be assessed by performing multiple sit-ups, knee flexions and knee extensions.

  12. Muscle endurance post-supplementation

    Time frame: Within 2 weeks after the end of supplementation.

    Muscle endurance will be assessed by performing multiple sit-ups, knee flexions and knee extensions.

Secondary outcomes

  1. Biochemical analyses pre-supplementation

    Time frame: Within 4 days before the beginning of supplementation.

    Plasma glucose, triacylglycerols, total cholesterol, HDL cholesterol, LDL cholesterol, urea, and creatinine (all in mg/dL) will be measured by chemiluminescence in an automated analyzer.

  2. Biochemical analyses post-supplementation

    Time frame: Within 4 days after the end of supplementation.

    Plasma glucose, triacylglycerols, total cholesterol, HDL cholesterol, LDL cholesterol, urea, and creatinine (all in mg/dL) will be measured by chemiluminescence in an automated analyzer.

  3. Hormonal analyses pre-supplementation

    Time frame: Within 4 days before the end of supplementation.

    Plasma cortisol and testosterone (both in μg/dL) will be measured by immunoluminescence in an automated analyzer.

  4. Hormonal analyses post-supplementation

    Time frame: Within 4 days after the end of supplementation.

    Plasma cortisol and testosterone (both in μg/dL) will be measured by immunoluminescence in an automated analyzer.

  5. Resting metabolic rate pre-supplementation

    Time frame: Within 2 weeks before the beginning of supplementation.

    Resting metabolic rate will be assessed with indirect calorimetry through the measurement of oxygen consumption with a metabolic analyzer.

  6. Resting metabolic rate post-supplementation

    Time frame: Within 2 weeks after the end of supplementation.

    Resting metabolic rate will be assessed with indirect calorimetry through the measurement of oxygen consumption with a metabolic analyzer.

  7. Internal load of exercise pre-supplementation

    Time frame: Within the first week of supplementation.

    Internal load of exercise will be assessed by telemetric heart rate sensors and software

  8. Internal load of exercise post-supplementation

    Time frame: Within the last week of supplementation (week 6).

    Internal load of exercise will be assessed by telemetric heart rate sensors and software

  9. Full blood count pre-supplementation

    Time frame: Within 4 days before the beginning of supplementation

    Full blood count will be performed by flow cytometry

  10. Full blood count post-supplementation

    Time frame: Within 4 days after the end of supplementation.

    Full blood count will be performed by flow cytometry

  11. Plasma enzymes pre-supplementation

    Time frame: Within 4 days before the beginning of supplementation.

    Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer

  12. Plasma enzymes post-supplementation

    Time frame: Within 4 days after the end of supplementation.

    Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer.

  13. Force-velocity relationship of shoulder muscles pre-supplementation

    Time frame: Within 2 weeks before the beginning of supplementation.

    Force-velocity relationship of shoulder muscles will be assessed by a linear encoder.

  14. Force-velocity relationship of shoulder muscles post-supplementation

    Time frame: Within 2 weeks after the end of supplementation.

    Force-velocity relationship of shoulder muscles will be assessed by a linear encoder.

  15. Maximal grip strength pre-supplementation

    Time frame: Within 2 weeks before the beginning of supplementation

    Maximal grip strength will be assessed by a hand dynamometer

  16. Maximal grip strength post-supplementation

    Time frame: Within 2 weeks after the end of supplementation.

    Maximal grip strength will be assessed by a hand dynamometer

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • European Commission
  • Greek Ministry of Development

Registry information

Official study title

Effects of Egg White Supplementation on Body Composition, Physical Performance, and Amino Acid Profile of Individuals Undergoing High-intensity Functional Training

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 31, 2022
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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